The production of biosimilar medicines is a complex and strictly regulated process. With the industry's continued advancement, biosimilars will become fundamental to expanding access to cutting-edge therapies.
Biosimilar drugs are revolutionizing the treatment of various chronic and serious conditions, such as autoimmune diseases, cancer, and endocrine disorders. As more biosimilars enter the market, they encompass a wide range of therapies, including vaccines, monoclonal antibodies, hormones, proteins, and others.
According to Tiago de Moraes Vicente, CEO of the Brazilian Association of Generic and Biosimilar Medicines Industries (PróGenéricos), the first regulation on biosimilars in Brazil was published in 2010. Filgrastim, a biosimilar drug used to stimulate white blood cell production in patients undergoing chemotherapy, radiotherapy, and/or bone marrow transplants, was the first biosimilar drug developed entirely in Brazil—and the first in Latin America.
“Biological medicines originated in the second half of the 20th century, although the initial concepts and experiments with protein-based therapies and biological products date back to earlier periods. But from the 1990s onwards, there was a growing need for a specific regulatory framework for the approval of biosimilar medicines. Europe was a pioneer in this area, establishing guidelines for biosimilars with the introduction of regulations by the European Medicines Agency (EMA) in the early 2000s," explains the president.
How are they made?
Target molecule selection:the first step is to select the biological medicine—indicated as a comparator by the health authority—that will serve as the basis for the development of the biosimilar. Generally, this choice falls on biological medicines whose patents have already expired or are about to expire.
Development of the manufacturing process:once the biological medicine has been selected, scientists work to develop a manufacturing process that produces the biosimilar in a consistent and reproducible manner. This involves choosing cell lines, culture media, and cultivation conditions that are suitable for producing the desired biological protein.
Characterization and comparison:The next step is to characterize the biosimilar medicine to ensure that it is similar to the biological medicine in terms of structure, function, and quality. This includes extensive analytical studies to compare the physical, chemical, and biological characteristics of the biosimilar with the reference medicine used for comparison purposes.
Pharmacodynamic and pharmacokinetic studies:Preclinical and clinical studies may be conducted in humans to demonstrate the biosimilarity of the drug with the comparator biological, if necessary. Robust analytical data studies, such as pharmacokinetic/pharmacodynamic (PK/PD) and immunogenicity studies, are generally required, with results being comparable in terms of efficacy and safety.
After successfully completing the studies, biosimilar drug manufacturers submit the data to regulatory agencies for review and approval. “The health authority thoroughly examines the data submitted to ensure that the biosimilar is safe, effective, and has the same effect as the pioneer biological drug before authorizing its commercialization,” explains the president.
Examples:
Monoclonal antibodies:biosimilar drugs that are monoclonal antibodies, such as rituximab and trastuzumab, can act by inhibiting the activity of specific proteins involved in biological processes, such as cell proliferation, immune response, or cell signaling. They are often used in the treatment of cancer and autoimmune diseases.
Growth factors:Biosimilar drugs that are growth factors, such as filgrastim, can stimulate blood cell production in the bone marrow, increasing white blood cell levels and reducing the risk of infections in patients undergoing treatments such as chemotherapy.
Hormones:Biosimilar medicines that are hormones, such as insulin, can act to regulate blood glucose levels by facilitating the absorption of glucose by cells and controlling the production and release of glucose by the liver.
Cytokines:proteins involved in regulating the immune system and communication between cells. These drugs can be used to modulate immune responses in diseases such as rheumatoid arthritis or psoriasis.
Biosimilars represent a revolution in medicine, providing effective and safe treatments for patients. As science continues to advance, the importance of these drugs is likely to expand significantly, reinforcing their positive impact on public health in Brazil and around the world.